NCT03092713

Combined Cognitive and Vocational Interventions After Mild-to-moderate TBI: a Randomized Controlled Trial

Completed NA Last updated 19 October 2021

What this trial tests

NA trial testing Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment) in Brain Injuries, Traumatic in 121 participants. Completed in 30 June 2021.

Timeline

2 January 2017

Primary endpoint
31 December 2020

30 June 2021

Quick facts

Lead sponsor	Oslo University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	121
Start date	2 January 2017
Primary completion	31 December 2020
Estimated completion	30 June 2021
Sites	1 location across Norway

Drugs / interventions tested

• Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment)
• Control Group — full drug profile →

Conditions studied

• Brain Injuries, Traumatic — all drugs for Brain Injuries, Traumatic →
• Cognitive Impairment — all drugs for Cognitive Impairment →

Sponsor

Oslo University Hospital

Who can join

Adults 18 to 60, any sex, with Brain Injuries, Traumatic or Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A considerable number of patients with mild and moderate traumatic brain injury (TBI) experience long-lasting somatic, cognitive, and emotional symptoms that may hamper their capacity to return to work (RTW). Although several studies have described medical, psychological and work-related factors that predict RTW after TBI, well-controlled intervention studies regarding RTW in this group are scarce. Furthermore, there have traditionally been weak collaborations among rehabilitation services in the health sector, the Labor and Welfare Administration (NAV), and the work-places.

The current project proposal describes an innovative randomized controlled trial (RCT) which will explore the effect of combined manualized cognitive rehabilitation efforts and supported employment in real-life competitive work settings for patients who have not returned to work 8 weeks post-injury. The project combines the rehabilitation and vocational science perspectives; it involves multidisciplinary collaboration, and explores the efficacy of increased cross-sectorial collaboration between specialized health care services and the welfare system. If the intervention proves efficient, the project will further describe the cost-effectiveness and utility of the program, and thereby provide important information of use for policy makers. In addition, the study aims at generating knowledge on the RTW-process both for the persons with TBI, and their workplaces, and to disseminate this knowledge in order to create new multidisciplinary and collaborative practices. The project has potential to generate knowledge of relevance for other patients with neurological deficit.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cost-effectiveness analysis of combined cognitive and vocational rehabilitation in patients with mild-to-moderate TBI: results from a randomized controlled trial.
   Howe EI, Andelic N, Fure SCR, Røe C, et al · · 2022 · cited 22× · PMID 35151285 · DOI 10.1186/s12913-022-07585-3
2. Combined cognitive and vocational interventions after mild to moderate traumatic brain injury: study protocol for a randomized controlled trial.
   Howe EI, Langlo KS, Terjesen HCA, Røe C, et al · · 2017 · cited 20× · PMID 29041954 · DOI 10.1186/s13063-017-2218-7
3. Effectiveness of Combining Compensatory Cognitive Training and Vocational Intervention vs. Treatment as Usual on Return to Work Following Mild-to-Moderate Traumatic Brain Injury: Interim Analysis at 3 and 6 Month Follow-Up.
   Howe EI, Fure SCR, Løvstad M, Enehaug H, et al · · 2020 · cited 12× · PMID 33240196 · DOI 10.3389/fneur.2020.561400
4. The relationship between personality traits and health-related quality of life after mild-to-moderate traumatic brain injury.
   Madsen BÅ, Fure SCR, Røe C, Løke D, et al · · 2025 · PMID 40217163 · DOI 10.1186/s12883-025-04153-0